BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 ANTERIOR BROACH HANDLE

    MDR report key: 14834727 · Received June 27, 2022

    Report

    Report Number
    1818910-2022-11849
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    March 8, 2022
    Report Date
    June 27, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTQ
    UDI-DI
    10603295230687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A-7381596 - (B)(6) 2022. UPDATE THE (B)(4), (B)(4), DECONTAMINATION STATUS, ANALYSIS SITE TO JRZ COMPLAINTS, QTY CHANGED FROM 0 TO 1; AVAILABLE TO AVAILABLE. THE DEVICE WAS RECEIVED AT PAL JRZ. 24/MAY/2022. A-7381580 - (B)(6) 2022. PC WAS REOPENED BECAUSE THE DEVICE WAS RECEIVED IN JRZ COMPLAINTS LAB. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043679 CORAIL2 ANTERIOR BROACH HANDLE HIP INSTRUMENTS : HANDLES HTQ DEPUY ORTHOPAEDICS INC US 952212500F SO2030831 10603295230687

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male